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The MD300W628 Wrist Pulse Oximeter is a portable, non-invasive device intended to measure, display, store and transfer functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR) of adult, adolescent and child in hospitals, clinics, long-term care, and home use.

The device intended for spot-checking and can be reused, not intended for continuous monitoring, use during motion or use with low perfusion.

The subject device Pulse Oximeter is an internally powered device. The main functions of the devices include hemoglobin oxygen saturation (SpO2), pulse rate (PR) measurements and Pulse amplitude index (PAI), data storage and transmission.

Place one fingertip into the sensor for diagnosis and the oxygen saturation (SpO2), pulse rate (PR) measurements and pulse amplitude index (PAI) will appear on the display. The device is normally applied to adult and pediatric patients in hospital and home care environment.

The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter, signal collection and process module (MCU), OLED display screen and Bluetooth module.

Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. The sensor contains a dual light source and photo detector. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

This FDA 510(k) summary provides information on the Beijing Choice Electronic Technology Co., Ltd. MD300W628 Wrist Pulse Oximeter, including its acceptance criteria and the studies conducted to demonstrate its performance.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document relies on compliance with recognized standards for its acceptance criteria, particularly ISO 80601-2-61 for pulse oximeter equipment accuracy.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Clinical Test (SpO2 Accuracy): 11 healthy adult volunteer subjects.
• Data Provenance: The clinical study was conducted at Yue Bei People's Hospital. The origin is inferred to be China, as Beijing Choice Electronic Technology Co., Ltd. is based in Beijing, China. The study appears to be prospective as it involved recruiting subjects and performing specific tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number of experts used or their qualifications for establishing ground truth. It mentions that the clinical study evaluated SpO2 accuracy "as compared to arterial blood CO-Oximetry." CO-Oximetry is the gold standard for measuring arterial oxygen saturation, and its results are considered highly accurate, typically not requiring expert interpretation for ground truth establishment in this context.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given that the ground truth for SpO2 accuracy was established using arterial blood CO-Oximetry, which is an objective measurement, an adjudication method for disagreements on ground truth would generally not be necessary for this specific performance metric.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted or of any effect size related to human readers improving with or without AI assistance. This device is a pulse oximeter, which provides direct physiological measurements, not interpretations that would typically involve multiple human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The SpO2 accuracy performance study described is essentially a standalone performance study. The device's measurement of SpO2 is directly compared to an objective gold standard (arterial blood CO-Oximetry), without human intervention in the interpretation of the device's output. The device itself (algorithm) provides the SpO2 reading.

7. Type of Ground Truth Used

The ground truth used for the SpO2 accuracy testing was arterial blood CO-Oximetry.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a training set. Pulse oximeters typically rely on established optical principles and signal processing algorithms rather than machine learning models that require large training datasets in the same way AI algorithms for image analysis might. The "algorithm" here refers to the signal processing rather than a deep learning model.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set in the context of typical machine learning, there is no information on how ground truth for a training set was established.

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MD300W512 / MD300W314/ MD300W314B4 is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, adolescent, child and infant patients. It is intended for spot-check and / or data collection, recording and transmitting. It can be used in sleep labs, long-term care, hospitals and home use.

The proposed devices Wrist Pulse Oximeter MD300W512 /MD300W314/MD300W314B4 are internally powered devices. The main functions of the devices include hemoglobin oxygen saturation (SpO2) and pulse rate (PR) measurements, visual and audible indication, data storage and transmission. The proposed device MD300W512/MD300W314/MD300W314B4 consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface, button control circuit, data storage and transmission module.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 12 healthy adult volunteer subjects.
• Data Provenance: The study was conducted in a hospital setting (Yue Bei people's Hospital) to evaluate the SpO2 accuracy performance of the MD300W512 Wrist Pulse Oximeter and its supporting M-50G010CS03 Oximeter probe. The text does not specify the country of origin but implies China, as the manufacturer is based in Beijing, China, and the hospital name is in Chinese. The study was prospective in nature, involving induced hypoxia and simultaneous blood sample collection.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. It mentions that "Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison." This implies that the reference CO-Oximetry results serve as the ground truth, which would typically be operated by trained medical professionals in a laboratory setting.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The ground truth was established by direct measurement using Reference CO-Oximetry, which is a quantitative and objective method, rendering adjudication for this specific ground truth less relevant than for subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The study focuses on the standalone performance of the device against a reference standard.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was conducted. The Wrist Pulse Oximeter directly measures and displays SpO2 and pulse rate. The clinical test evaluated the device's accuracy directly against a reference CO-Oximetry, without human interpretation as part of the primary measurement.

7. Type of Ground Truth Used

The ground truth for SpO2 accuracy was established using Reference CO-Oximetry analysis of arterial blood samples. This is an objective, gold-standard method for determining arterial oxygen saturation (SaO2).

8. Sample Size for the Training Set

The document provided does not specify a separate training set or its sample size. The description pertains to the clinical test set used for validation of the device's performance.

9. How the Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned or detailed in the provided text, the method for establishing its ground truth is not available from this document. The document describes the ground truth for validation (test set) as being established by Reference CO-Oximetry.

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The Wrist Pulse Oximeter is intended for spot checking in measuring and displaying oxygen saturation of functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospital facilities and home healthcare environments.

This device is a small, lightweight, portable device intended for use in measuring and displaying oxygen saturation of functional arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senror and displays on the OLED after certain further processing. The device is mainly composed of the motherboard, SpO2 transducer and built-in battery. The power supply is 4.2V Li-battery and also the subject device can be powered by adapter. The subject device has a detachable sensor as an accessory to measure the SpO2 and pulse rate (PR). The subject device is not for life-supporting or life-sustaining and it is not an implantable device. The subject device owns software which has been validated by the manufacturer.

Here's a breakdown of the acceptance criteria and study findings for the Wrist Pulse Oximeter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The relevant acceptance criteria and performance data for the Wrist Pulse Oximeter primarily come from the "Substantial Equivalence" section and the "Clinical Test" section.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The clinical evaluation was conducted on a total of 24 healthy adult male and female volunteers.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study participants beyond mentioning "2 white people, and 15 yellow-skin people." It is implied to be a prospective study as it describes a clinical evaluation conducted to generate data for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. For pulse oximetry, the ground truth is typically established by arterial blood gas (ABG) analysis, which is a laboratory measurement, not directly by "experts" in the sense of human readers. The clinical study compares the device's readings against these reference measurements.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method in the context of human expert review for the test set. For a pulse oximeter, the "ground truth" is typically objective physiological measurements (ABG), not subjective expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A MRMC study is typically performed for image-based diagnostic aids where the AI assists human readers. This document describes a medical device (pulse oximeter) that provides a direct physiological measurement, and its accuracy is validated against a gold standard (ABG), not via a comparative effectiveness study with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes. The primary study detailed is a standalone performance validation of the Wrist Pulse Oximeter where its measurements (SpO2 and pulse rate) are compared directly against a reference method (likely arterial blood gas measurements, though not explicitly stated for SpO2, it's the standard for oximeter validation). The reported SpO2 accuracy of ±2% is an algorithm-only performance metric.

7. The Type of Ground Truth Used

The ground truth for the SpO2 accuracy validation was established using a physiological reference standard. While not explicitly named for SpO2 in the clinical test section, the widely accepted and regulatory-mandated method for validating pulse oximeter accuracy (specifically the Arms value) involves inducing various levels of hypoxemia and comparing the oximeter readings to co-oximeter measurements of arterial blood samples (Arterial Blood Gas - ABG).

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. The description of validation usually pertains to the final, locked algorithm or device. For devices like pulse oximeters, the core algorithm is often developed based on photometric principles and extensive internal testing, rather than a "training set" in the machine learning sense. The clinical test described is a validation test, not a training activity.

9. How the Ground Truth for the Training Set was Established

As no training set is described in the document, there is no information provided on how ground truth for such a set (if it existed) was established. Device development often involves internal calibration and verification, but these details are not typically part of a 510(k) summary focused on regulatory validation.

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The MD300W4 wrist pulse oximeter is a portable non-invasive device intended for spot checking ,data collection and recording of arterial oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at home and hospital( including clinical use in internist/ surgery, Anesthesia, intensive care and etc).

The proposed device MD300W4 consists of MCU circuit, power supply circuit, SpO2 module circuit, display circuit, Flash memory circuit, GPRS module circuit, charging circuit, real-time clock circuit, button circuit.
It can measure, store, review and display the SpO2% and pulse rate value, time, ID number, pulse bar and battery power status, the connection of probe, and transmit data by GPRS or USB cable.
The power supply is 4.2V Li-battery with capacity 1250mAh. The device can not be used to measure when it charges for the Li- battery.
The Pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and a photodetector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is infrared light.
Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in probe collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
The proposed device has one model detachable sensor as the accessory of which the skin-contacting material is silicon. It is listed below:
M-50G (510(k) number: K082487)
The proposed device is not for life-supporting or life-sustaining, not for implant. The device or probe is not sterile and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products.
The device is software-driven and the software validation is provided in Section 14 Software on page 14-1.

Here's an analysis of the provided text to fulfill your request:

Acceptance Criteria and Device Performance Study for Wrist Pulse Oximeter MD300W4 (K122046)

Based on the provided 510(k) summary, the device is a modified Wrist Pulse Oximeter, MD300W4, and its performance is evaluated against the predicate device, MD300W (K081125), and established standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MD300W4 are largely aligned with its predicate device and industry standards for pulse oximeters. The reported device performance is presented as compliance with these specifications.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: 12 health adults.
• Data Provenance: Prospective clinical test conducted in Yue Bei People's Hospital. The country of origin can be inferred as China, given the manufacturer's location and the hospital name.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not specify the number of experts or their qualifications for establishing the ground truth. It states that SpO2 values were compared to "arterial blood sample oxygen saturation (functional SaO2) as measured by CO-Oximetry," referring to this as the "Golden Standard Co-Oximeter." This implies a technical measurement-based ground truth rather than expert consensus on subjective interpretations.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. The ground truth is established directly by a "Golden Standard" Co-Oximeter for arterial blood sample oxygen saturation, rather than through subjective expert review requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a pulse oximeter, which directly measures physiological parameters (SpO2 and pulse rate) and does not involve "human readers" interpreting images or data in the context of an "AI" system that would enhance human performance. The study described is a clinical accuracy study comparing the device's readings against a reference method.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The clinical test described involved comparing the device's SpO2 measurements directly against arterial blood sample oxygen saturation measured by a CO-Oximeter. This assesses the device's algorithmic performance in isolation (determining SpO2 from its sensor input) without human intervention in the measurement process itself, beyond the initial setup.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The type of ground truth used was objective measurement data from a "Golden Standard" Co-Oximeter measuring functional SaO2 from arterial blood samples. This is considered a highly accurate and direct physiological measurement.

8. The Sample Size for the Training Set

The document does not mention a separate training set or its sample size. The clinical test described appears to be for validation/testing, not for training a machine learning model. For a traditional medical device like a pulse oximeter, the core algorithm for converting optical signals to SpO2 and PR is typically based on established physiological models and calibration, rather than iterative machine learning training on a large dataset in the way an AI diagnostic algorithm would be.

9. How the Ground Truth for the Training Set Was Established

As no separate training set is mentioned (or implied as relevant for this type of device's core function), the method for establishing ground truth for a training set is not applicable based on the provided information.

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The MD300W wrist oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital ( including clinical use in internist/ surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.

The applicant device of Wrist Pulse Oximeter MD300W is a wrist-worn device, which can display %SpO2, pulse rate value and vertical bar graph pulse amplitude,

The applicant device consists of sensor, signal amplify unit, CPU, data display unit, data transmit unit, storage and power unit.

The wrist oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light.

Skin, bone, tissue, and venous vessels normally absorb a constant amount of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

The applicant device has low battery voltage alarm function and automatically power of function. The power source of the applicant device is 1 AAA alkaline batteries.

The applicant device is not for life-supporting or life-sustaining, not for implant. The device or sensor are not sterile and the sensor does not need sterilization and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Wrist Pulse Oximeter MD300W:

Please note: The provided text is a 510(k) Summary for a medical device. These summaries typically contain a high-level overview and refer to more detailed reports (like clinical test reports) in their appendices. Therefore, some detailed information might not be explicitly stated in this summary but would be found in the referenced documents.

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for the clinical test. The summary mentions "adult and pediatric patient," but the number of subjects is not provided.
   • Data Provenance: Clinical tests were "conducted in Wulanchabu City Center Hospital" and "Laboratory of Beijing Friendship Hospital." This suggests the data is prospective clinical trial data from China.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not explicitly provided in the 510(k) summary. For pulse oximetry clinical studies, ground truth is typically established using a co-oximeter measuring arterial blood gas samples, not expert consensus in the traditional sense of image interpretation.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not applicable to a pulse oximetry accuracy study where ground truth is established through instrumental measurement (co-oximetry) rather than expert review. There's no "adjudication" necessary for the primary outcome.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that involves human readers interpreting results.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance assessment was done. The clinical test assesses the accuracy of the device itself (algorithm and hardware) against a reference standard without human interpretation. The summary states: "The Clinical Test reports following ISO 9919:2005... are conducted in Wulanchabu City Center Hospital provided in Attachment IV Clinical Test Reports."

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The ground truth for pulse oximeter accuracy studies is typically established by arterial blood gas analysis using a co-oximeter. While not explicitly named in the summary, conformance to ISO 9919:2005 (which specifies requirements for in vivo clinical testing) implies this method. ISO 9919:2005 requires comparing the device's SpO2 readings to simultaneously drawn arterial blood samples analyzed by a laboratory co-oximeter.

7. The sample size for the training set:

   • This information is not applicable/not provided. Pulse oximeters of this type, especially from this era (2008), typically rely on established physiological models and calibration rather than machine learning "training sets" in the modern AI sense. While internal calibration data would be used, it's not a "training set" for an algorithm that learns from data.

8. How the ground truth for the training set was established:

   • As noted above, the concept of a "training set" and associated ground truth is not directly applicable in the context of this device's type and the information presented. The device's underlying principles are based on the Beer-Lambert law and physiological light absorption, not a learned AI model.

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